BEUDAMED
    FDA Adverse Event Other Summary report: N

    SARNS 9000 PERFUSION SYSTEM, 115 V

    MDR report key: 142570 · Received January 12, 1998

    Report

    Report Number
    1828100-1998-00001
    Event Type
    Other
    Date Received
    January 12, 1998
    Date of Event
    December 11, 1997
    Report Date
    January 12, 1998
    Manufacturer
    3M HEALTH CARE/ SARNS AND CDI PRODUCTS
    Product Code
    DTQ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING THE OPERATION, THE UPPER HALF OF THE CONSOLE'S COLOR SCREEN WENT DIM, AND SOME SMOKE CAME FROM THE UNIT. NO PT INJURY HAS BEEN REPORTED AS A RESULT OF THIS INCIDENT. THE PRESENCE OF SMOKE IN THE OPERATING ROOM CREATES A POTENTIALLY DANGEROUS SITUATION FOR BOTH THE PT AND THE USERS OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SARNS 9000 PERFUSION SYSTEM, 115 V HEART-LUNG MACHINE DTQ 3M HEALTH CARE/ SARNS AND CDI PRODUCTS 98-0702-0270-4 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other